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FDA Recalls

Showing 10 of 18043 recalls

Data updated: 2026-10-21 03:36:05

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Benzoyl Peroxide Wash, USP, 5%, 5 FL OZ (148 mL), Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1259-63 Class II

Reason: Microbial contamination of topical product.

SV Labs Toronto Corporation 20260901 Ongoing

Distributed: IL only

Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-179-05 Class II

Reason: Crystallization

Par Health USA, LLC 20260908 Ongoing

Distributed: U.S. Nationwide

Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807. NDC: 27241-126-02 Class II

Reason: Failed Dissolution Specifications: below specification

Ajanta Pharma USA Inc 20260917 Ongoing

Distributed: Nationwide in the US.

TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Sterile Eye Drops, 0.5 FL OZ (15 mL) bottles, Manufactured exclusively for TRP Company, Inc. 1575 Delucci Ln, Reno, NV 89502, NDC 17312-430-15. Class II

Reason: Lack of Assurance of Sterility

Sterling Pharmaceutical Services LLC 20260820 Ongoing

Distributed: USA Nationwide

AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) EACH, 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-02 (carton) Class II

Reason: Lack of Assurance of Sterility

Sterling Pharmaceutical Services LLC 20260820 Ongoing

Distributed: USA Nationwide

Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) with Hang Tag, 0.5 fl oz (15mL) per dropper bottle, STERILE, Dist. by Medtech Products Inc., Tarrytown, NY 10591. NDC: 67172-797-15 Class II

Reason: Lack of Assurance of Sterility

Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company 20260915 Ongoing

Distributed: Nationwide in the USA.

AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) bottle, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-15 Class II

Reason: Lack of Assurance of Sterility

Sterling Pharmaceutical Services LLC 20260820 Ongoing

Distributed: USA Nationwide

Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.5%, Eye Lubricant, 0.5 FL OZ (15 mL) bottles, Distributed by Cameron Pharmaceuticals, LLC, Louisville, KY, 40245, NDC 42494-448-05 Class II

Reason: Lack of Assurance of Sterility

Sterling Pharmaceutical Services LLC 20260820 Ongoing

Distributed: USA Nationwide

Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, NDC 69618-077-55. Class II

Reason: Lack of Assurance of Sterility

Sterling Pharmaceutical Services LLC 20260820 Ongoing

Distributed: USA Nationwide

Walgreens Lubricant Eye Drops, 0.5 FL OZ (15 mL) 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by Walgreens Co., 200 Wilmot Road, Deerfield, IL 60015, NDC 0363-8833-15. Class II

Reason: Lack of Assurance of Sterility

Sterling Pharmaceutical Services LLC 20260820 Ongoing

Distributed: USA Nationwide

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Data provided by openFDA